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EP2939629B1 - Appareil d'occlusion d'un vaisseau par embolisation rf - Google Patents

Appareil d'occlusion d'un vaisseau par embolisation rf Download PDF

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Publication number
EP2939629B1
EP2939629B1 EP15275109.5A EP15275109A EP2939629B1 EP 2939629 B1 EP2939629 B1 EP 2939629B1 EP 15275109 A EP15275109 A EP 15275109A EP 2939629 B1 EP2939629 B1 EP 2939629B1
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EP
European Patent Office
Prior art keywords
electrode element
control unit
vessel
power supply
operable
Prior art date
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Not-in-force
Application number
EP15275109.5A
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German (de)
English (en)
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EP2939629A3 (fr
EP2939629A2 (fr
Inventor
Per Elgaard
Allan Torp
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Cook Medical Technologies LLC
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Cook Medical Technologies LLC
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Publication of EP2939629A3 publication Critical patent/EP2939629A3/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00075—Motion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A61B2018/00416—Treatment of aneurisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589—Coagulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/0063—Sealing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A61B2018/00654—Sensing and controlling the application of energy with feedback, i.e. closed loop control with individual control of each of a plurality of energy emitting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the present invention relates to apparatus for occluding or closing a vessel by means of RF embolization.
  • RF ablation in which an electrical terminal is fed endoluminally into the vessel and an electrical pulse at RF frequencies applied to the electrical terminal.
  • the conductivity of blood and/or the vessel tissues causes localised heating. This heating can be used to cause damage to the tissue (intima) of the vessel wall, resulting in vessel contraction.
  • RF ablation heats the surrounding blood, causing this to coagulate around the electrical terminal and form a blood clot which blocks the vessel.
  • Two types of RF ablation apparatus are generally contemplated in the art, the first being a monopolar system having an elongate anode terminal and a cathode pad.
  • the anode terminal is designed to be fed endoluminally into the patient's vessel, while the cathode pad is positioned against the person's outer body, as close as practicable to the anode terminal. Electrical energy applied to the anode terminal will pass by conduction through the patient to the cathode pad. There will be localised heating at the anode terminal, which effects the desired ablation.
  • a problem with monopolar systems is that it can be difficult to control the extent of damage to surrounding tissues and organs, as well as to the vessel wall. This risks damaging the vessel to the point of rupture, as well as possible irreversible damage to neighbouring organs.
  • Another RF ablation system uses a bipolar arrangement, in which an elongate electrical element includes both the anode and cathode terminals, which are spaced longitudinally from one another at a distal end of the electrical element.
  • Current passes between the anode and the cathode terminals through the surrounding blood, causing localised heating and coagulation of the blood.
  • a bipolar system has been considered to provide more localised heating and therefore reduced risk of damage to surrounding organs and tissue.
  • the electrical terminal can become attached to the vessel wall tissue, with the risk of tearing and rupturing the vessel wall.
  • a system which ablates the surrounding blood to generate a blood clot in the vessel there is the risk that the blood clot is dragged with the electrical element and that the occlusion of the vessel is as a consequence lost.
  • the present invention seeks to provide improved apparatus for occluding or closing a body vessel.
  • apparatus as in claim 1.
  • the apparatus disclosed herein provides for closing any opening or lumen left by the retracting or retracted electrical element, namely by applying energy through the electrical element, at a power level less than the initial ablation power, which has the effect of causing secondary blood coagulation.
  • the second power level is insufficient to cause the creation of a further vessel occluding barrier, that is a second barrier which closes off the vessel in its entirety.
  • the application of the power at the second level stops once sufficient blood has coagulated to close any aperture left by the retracted or retracting electrical element.
  • the occluding barrier created by application of power at the first power level will therefore form the total length of effective vessel occlusion, thereby making the method also suitable in vessel zones having short treatment sites, such as in locations with adjacent vessel side branches and the like.
  • the apparatus includes a user notification unit coupled to the control unit, the control unit being operable to generate a notification on detection of the operational change in the at least one electrical terminal.
  • the notification unit could be a visual notification, an acoustic notification, a vibratory notification, a combination of any of these, or any other suitable notification.
  • Partial retraction may leave a part of the electrode tip within the formed clot, thereby to keep any aperture therein closed and to ensure that the second phase of ablation takes place within the blood clot and able to close off the residual lumen.
  • the apparatus may include a positioning, or drive, unit coupled to the control unit, the positioning unit being operable to effect the partial retraction of the electrode element in the proximal direction on detection of the operational change.
  • the control unit may be operable to generate a notification to effect said partial retraction of the electrode element.
  • the operational change preferably includes at least one of: change in measured impedance and change in temperature.
  • thermosensor at the distal end of the electrode element.
  • control unit may be operable to command the power supply to supply power to the electrode element until the electrode element has been retracted by a predetermined distance.
  • the predetermined distance may be equivalent to a desired length of closure of the vessel.
  • the system of this embodiment is able to create an occluding barrier of varying length.
  • the electrode element includes an anode terminal, the apparatus including a cathode pad.
  • the system may be a monopolar system.
  • the electrode element includes anode and cathode terminals.
  • the system may be a bipolar system.
  • a positioning unit coupled to the control unit, the positioning unit being operable to move the electrode element in at least a proximal direction.
  • a positioning unit can therefore provide an automated ablation system.
  • the elongate electrode element can be for being passed endoluminally to a treatment site.
  • the preferred embodiments are designed to create blood clotting, that is to ablate the blood surrounding the electrical element. This can be achieved by selecting an ablation energy level and an ablation time duration suitable to heat surrounding blood, which in some circumstances can be expected to be less than the energy required to ablate the vessel tunica, although there may be experienced some contraction of the vessel as a result of the heating of the blood.
  • the skilled person will be able to determine suitable ablation parameters from common general knowledge in the art.
  • the preferred embodiment uses a thin, that is narrow diameter, electrode which minimises the surface area contact with the vessel wall in circumstances where the distal end of the electrode is not deployed in the centre of the vessel.
  • the level of power applied through the electrode and the time of application will be dependent upon factors including the size of the vessel, the amount and speed blood flow through the vessel, pulsation and turbulence of blood at the point of ablation, and so on.
  • FIG. 1 this shows in schematic form an embodiment of monopolar RF ablation system 10 having an elongate electrode element 12 and a cathode pad 14.
  • the elongate electrode element 12 is designed to be passed endoluminally through the vasculature of a patient up to a treatment site 16 of a vessel 18, that is to the position in a vessel as which it is desired to close or occlude the vessel 18.
  • the electrode element 12 includes a distal end 20 which in this embodiment has an exposed electrode terminal 22 acting as the anode of the circuit.
  • the electrode element 12 in some embodiments also includes a temperature sensor 24 for measuring temperature at the anode terminal 22, useful in determining the progress of ablation of the vessel.
  • the electrode element 12 also includes a sheath 26 of electrically insulating material which in practice covers the remainder of the electrode 22, such that a current path in use exists solely from the exposed terminal 22 at the distal end 20 of the electrode element 12.
  • the electrode element 12 is coupled electrically to a control unit 40, as is the cathode pad 14.
  • the control unit 40 is operable to provide energy to the electrode element 12, specifically current at RF frequencies.
  • the anode terminal 22 and cathode pad 14 form a circuit for the RF energy, which will conduct through a patient's body between the anode terminal 22 and the cathode pad 14.
  • the cathode pad 14 will be applied against the patient's skin, preferably at a position which is practicably as close as possible to the anode terminal 22, in order to provide this conduction path.
  • the control unit 40 typically includes a processing unit 42, a power delivery circuit 44 coupled to the anode and cathode elements of the system 10, typically one or more sensors including a temperature sensor unit 40 coupled to the temperature probe 24 and/or an impedance sensor unit 48 for measuring impedance between the anode 22 and cathode 14 of the system 10.
  • a temperature sensor unit 40 coupled to the temperature probe 24 and/or an impedance sensor unit 48 for measuring impedance between the anode 22 and cathode 14 of the system 10.
  • both of types of sensor units 46 and 48 may be provided.
  • the control unit 40 may also include an electrode drive unit 50 for moving the electrode 12 within the patient's vessel 18.
  • the control unit 40 may be provided with a position sensor for measuring the position of the electrode 12 within a patient and in particular for measuring the retraction of the electrode 12 from within the vessel 18.
  • Some embodiments may include both a drive unit 59 and a position sensor.
  • the processing unit 40 also includes a user interface 60 coupled to the control unit 40 and operable to provide data to a user and for input of user commands to the control unit 40.
  • the user interface 60 may, in its simplest embodiment, include an on/off switch for operating the control unit 40 and therefore the RF ablation, with the control unit 40 then effecting the desired ablation process under the command of the unit 40 solely.
  • the user interface 60 may be more sophisticated and enable, for example, a user to select different modes of ablation and also to produce, for instance, occluding barriers of different lengths, as described in further detail below.
  • the user interface 60 preferably also includes an output for providing ablation feedback and/or warning signals to a user. It may, for example, provide an indication of measured temperature and/or impedance, an indication of progress of ablation of the vessel and so on.
  • the user interface 60 may include a visual unit, for example a display to display quantitative data such as graphs, measures of temperature and impedance, determined length of occlusion and so on.
  • the display may be simpler, having for instance simple visual indicators such as one or more illuminated lamps.
  • the output could also be an acoustic output and/or, as appropriate, a tactile output such as a vibration generator and so on. Any combination of user feedback devices may be provided.
  • the apparatus 10 of Figure 1 is intended to cause heating of blood within the vessel 18 so as to occlude the vessel by the formation of a blood clot, rather than by ablation and damage of the tunica (tissues) of the vessel wall.
  • Figures 2A to 2D show in schematic form the preferred mode of operation of the apparatus 10 of Figure 1 and method of ablating a vessel 18.
  • the control unit 40 commands the power unit 44 to supply RF energy to the electrode 12, as a result of which current passes from the exposed terminal tip 22 into the volume of the vessel 18, passing through the body of the patient to the cathode pad 14.
  • the energy concentration at the electrode 22 causes local heating of blood and as a result coagulation of the blood to form a clot 70 around the exposed terminal tip 22.
  • This phase of the operation of the apparatus 10 preferably occurs at first power level which is relatively high, indicated as such in the depiction of the meter display 62 in Figure 2A .
  • the progress of ablation in this phase is preferably controlled by one or more sensors, for instance by means of a temperature probe 24 and temperature sensor unit 46 in the control unit 50 and/or by measuring the impedance of the circuit formed by the apparatus 10 when in operation.
  • sensing temperature will aim to detect an increase in temperature indicative of passing a threshold at which blood will coagulate to form a clot 70, whereas measurement of impedance will determine when a sufficient amount of blood has clotted around the anode tip 22 to cause a drop in measured current and consequential increase in impedance.
  • the electrode element 12 is partially retracted, such that the anode tip 22 is at least partially exposed outside the blood clot 70.
  • the withdrawal of the anode tip 22 will generally leave an aperture or lumen 72 within the blood clot 70.
  • the anode tip 22 is only partially removed from within the volume of the blood clot 70, although in other embodiments the anode tip 22 may be fully retracted from the blood clot 70 so that the distal end of the anode tip 22 lies close to the blood clot 70 but not therewithin.
  • a cathode tip of around 10mm or so may be retracted by 2 to 10 mm at the end of the first phase of the process.
  • control unit 50 commands the power unit 44 to apply energy at a second power level lower than the first power level applied during the phase of Figure 2A .
  • control unit 50 may command the power unit 44 to apply no power at, that is until after the partial retraction of the anode tip 22.
  • retraction of the anode tip 22, by means of retraction of the electrode element 12 may be effected manually by the medical practioner or automatically by means of a drive unit 50 provided in or coupled to the control unit 40.
  • a suitable drive unit will be apparent to someone of average skill in the art.
  • the control unit 40 commands the power unit 44 to apply energy at the second, lower, power level, which causes further ablation of blood within the vessel 18.
  • this phase of operation of the apparatus 10 causes blood within the lumen 72 to coagulate and thereby form an additional blood clot 80 within the lumen 70 so as to close off the lumen 70, as well as further relatively minor blood coagulation around the exposed part of the anode tip 22 to form clotted blood 82 therearound.
  • the volume of the blood which is clotted is substantially less and preferably such as not to alter notably the length of the blood clot 70 produced in the first phase of the process shown in Figure 2A . Therefore, the occluding barrier 70 preferably remains substantially the same length even in this second phase of RF ablation process. Specifically, the secondary blood clotting 82 is insufficient to fill the width of the vessel 18 and in practice will not obstruct any side vessels. The effective length of the blood clot will remain the length of the primary blood clot 70.
  • the degree of clotting during the second phase of the ablation process of Figure 2C can again be sensed by the temperature probe 24 and temperature sensor unit 46 and/or by the impedance unit 48. It will be appreciated that the temperature reached during this second phase of and/or the impedance change may very well differ from the those experienced during the first phase of the process, depicted in Figure 2A . The person skilled in the art will be able to determine suitable thresholds for achieving such secondary clotting 80, 82.
  • the process of partial retraction and RF ablation at a lower power level depicted in Figure 2C can be carried out a plurality of times during the process.
  • the anode tip 22 may be retracted only a small distance from within the blood clot 70, the second phase carried out, the anode tip 22 retracted a little further, the second ablation phase operated again and so on, until it has been deemed that a sufficient secondary barrier 80 has been produced within the lumen 72 of the first formed blood clot 70.
  • the second phase may be carried only once.
  • the electrode and consequently the anode tip 22 are completely retracted from the treatment site and the vessel 18, thereby to leave a blood clot formed of a first blood clot 70 and secondary blood clots 80, 82.
  • the control unit 50 will have commanded the power unit 44 to cut all power to the electrodes 22, 14.
  • a blood clot formation 70-82 which is completely sealed and which, moreover, is not unduly long.
  • Figures 3 to 5 are flow charts depicting three different modes of operation of the apparatus 10 of Figure 1 , carried out by the control unit 40.
  • the skilled person will appreciate that the apparatus 10 can be operated also in modes other than those described in connection with Figures 3 to 5 .
  • the skilled person will also appreciate that the control unit 40 may be set up to operate in a single mode of operation, but that in other embodiments may be programmed to operate in one of a plurality of modes of operation, as desired by the practitioner or required for the medical indication.
  • the electrode element 12 is, at step 100, inserted endoluminally into a patient's vessel up to the treatment site.
  • RF energy is applied to the anode tip 22 while measuring the temperature of the tip 22 and/or impedance through the circuit.
  • the control unit 40 and in particular the processing unit 42 by continuous monitoring of temperature and/or impedance, determines whether the temperature and/or impedance has reached a first threshold indicative of generation of blood clot 70. If the threshold has not been reached, the control unit 40 continues commanding the power unit 44 to apply energy to the anode tip at the first energy level.
  • the processing unit 42 commands at step 108 the power unit 44 to apply RF energy to the anode tip 22 at reduced power, while continuing to measure temperature and/or impedance.
  • the processing unit 44 continues monitoring the temperature and/or impedance at step 110 to determine therefrom whether this has reached a second threshold level. If the second threshold is deemed not to have been reached at step 110, the system continues operating in accordance with step 108, that is to apply energy at the reduced power level.
  • the processing unit 42 switches off power at step 112, on the basis that the condition at Figure 2C is deemed to have been reached.
  • the electrode element 12 and therefore the anode tip is removed from the vessel.
  • the electrode element 12, and therefore anode tip are inserted endoluminally into the vessel, as in step 100 of the embodiment of Figure 3 .
  • the processing unit 42 detects the position of the anode tip within the vessel. If at step 204 it is determined that the anode tip is being retracted, operation proceeds to step 206. On the other hand, if it is not detected that the anode tip is being retracted, the process returns to step 202 to continue applying RF energy while continuing to monitor the position of the anode tip. When it is determined that the anode tip is being retracted, the process proceeds to step 206 at which energy continues to be applied to close the thrombus formation.
  • This energy is in the preferred embodiment applied at the lower energy level in order to create secondary thrombus formations as shown in Figure 2C .
  • energy can be applied at the first power level or a power level sufficient to cause greater, that is larger, thrombus formation and further occlusion of the vessel.
  • the processing unit 42 continues to monitor the position of the anode tip 22 and when it is determined that it has been retracted by a predetermined distance deemed sufficient to close the thrombus formation 70, the processing unit 42 moves to step 210, at which it commands the power unit 44 to switch off power to the terminals 22. Then, at step 212, the electrode element 12 and therefore the anode tip 22 are removed from the vessel.
  • the embodiment of Figure 4 does not measure changes in temperature and/or impedance during the RF ablation process and the system continues applying RF energy where it is determined that the anode tip is being retracted.
  • This embodiment therefore, in its simplest form avoids leaving an open lumen 72 within the formed blood clot 70, which could as a result lead to incomplete occlusion of the vessel 18 and risk of recanalization.
  • the embodiment of Figure 4 could also include steps to measure temperature and/or impedance and to determine whether these have reached the first and/or the second thresholds disclosed above in connection with the embodiment of Figure 3 .
  • FIG. 5 Another embodiment of mode of operation of the apparatus 10 of Figure 1 is shown in Figure 5 .
  • electrode element 12 and therefore anode tip 22 are introduced into the vessel to the location at which treatment is to be carried out.
  • step 302 the control unit 42 commands the power unit 44 to apply RF energy to the anode tip 22, whilst at the same time measuring temperature and/or impedance at the anode tip 22.
  • step 304 the processing unit 42 determines whether the temperature and/or impedance has reached the first threshold and if it has not, step 302 continues to operate. On the other hand, when it is determined at step 304 that the first threshold has been reached, operation passes to step 306, at which the control unit commands retraction of the anode tip 22 by a given distance. This may be by operating the drive unit 50 shown in Figure 1 or by displaying on a user interface a command instructing the user to effect the necessary withdrawal (the user can equally be warned by an acoustic and/or vibratory command).
  • the processing unit 42 determines whether the anode tip 22 has been retracted by a desired distance. This distance is deemed to be the desired total length of the occluding barrier formed by the blood clot 70. If it is deemed that the anode tip has not been retracted by the desired distance, the process returns to step 302 to continue applying RF energy. It is to be understood that in returning to step 302 a blood clot of the type shown in Figure 2A will be generated, but more proximally, in effect to extend the length of the blood clot 70 to create a longer occluding barrier extending radially all the way to the vessel walls.
  • step 308 it has been determined that the anode tip has been retracted by the desired distance, typically equivalent to the desired length of the blood clot 70, the process passes to step 310, at which power is switched off and then, at step 312, the electrode element 12 and anode tip 22 are removed from the patient.
  • control unit 40 and in particular the processing unit 42 may command a process equivalent to steps 108 and 110 in the embodiment of Figure 3 in order to create a secondary occlusive barrier 80, 82 in order to close off any lumen in the formed blood clot 70. It is also to be understood that a phase of reduced power may be effected between steps 306 and 308 of the embodiment of Figure 5 , to create a progressive barrier 80 within the lumen 72 of the formed blood clot 70.
  • the embodiment of Figure 5 will then apply power at a higher power level over a longer period of time in order, in effect, to grow the blood clot 82 at the exposed end of the anode tip 22 until the latter is deemed to have filled the volume of the vessel 18, that is grown into abutment with the vessel walls.
  • Figure 5 can be used to create an occlusion of varying lengths as well as ensuring closure of the lumen left by the retracting anode tip 22.

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Claims (9)

  1. Appareil permettant de fermer un vaisseau sanguin comprenant :
    un élément d'électrode allongé (12) destiné à être passé de manière endoluminale vers un site de traitement et possédant au moins une borne électrique au niveau d'une extrémité distale de celui-ci ;
    une alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) ;
    une unité de détection pour détecter au moins un changement fonctionnel au niveau de l'au moins une borne électrique, la détection de l'au moins un changement fonctionnel consistant à déterminer si une température et/ou une impédance ont atteint un premier seuil ;
    une unité de commande (40) connectée à l'alimentation électrique et à l'unité de détection ; l'unité de commande (40) étant exploitable pour commander l'alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) à un premier niveau de puissance pour provoquer une coagulation sanguine principale, pour détecter l'au moins un changement fonctionnel au niveau de l'au moins une borne électrique et pour commander l'alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) à un second niveau de puissance inférieur au premier niveau de puissance pour provoquer une coagulation sanguine secondaire une fois que le changement fonctionnel a été détecté ;
    dans lequel l'unité de commande (40) est exploitable pour commander une rétraction partielle de l'élément d'électrode (12) dans une direction proximale lors de la détection du changement fonctionnel.
  2. Appareil selon la revendication 1, comprenant une unité de positionnement couplée à l'unité de commande (40), l'unité de positionnement étant exploitable pour effectuer ladite rétraction partielle de l'élément d'électrode (12) dans une direction proximale lors de la détection dudit changement fonctionnel.
  3. Appareil selon la revendication 1, dans lequel l'unité de commande (40) est exploitable pour générer une notification pour effectuer ladite rétraction partielle de l'élément d'électrode.
  4. Appareil permettant de fermer un vaisseau sanguin comprenant :
    un élément d'électrode allongé (12) destiné à être passé de manière endoluminale vers un site de traitement et possédant au moins une borne électrique au niveau d'une extrémité distale de celui-ci ;
    une alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) ;
    une unité de commande (40) connectée à l'alimentation électrique ;
    un capteur de position d'électrode couplé à l'unité de commande (40) ;
    dans lequel l'unité de commande (40) est exploitable pour commander l'alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) à un premier niveau de puissance pour provoquer une coagulation sanguine principale, et pour commander l'alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) à un second niveau de puissance inférieur au premier niveau de puissance pour provoquer une coagulation sanguine secondaire lorsqu'une rétraction partielle de l'élément d'électrode (12) a été détectée.
  5. Appareil selon la revendication 4, dans lequel l'unité de commande (40) est exploitable pour commander l'alimentation électrique pour fournir de l'énergie à l'élément d'électrode (12) jusqu'à ce que l'élément d'électrode ait été rétracté à raison d'une distance prédéfinie ; dans lequel la distance prédéfinie est de préférence équivalente à une longueur souhaitée de fermeture du vaisseau.
  6. Appareil selon l'une quelconque des revendications 1 à 3, comprenant une unité de notification d'utilisateur couplée à l'unité de commande, l'unité de commande étant exploitable pour générer une notification lors d'une détection du changement fonctionnel dans l'au moins une borne électrique.
  7. Appareil selon l'une quelconque des revendications 1 à 3 ou 6, dans lequel le changement fonctionnel comprend au moins un parmi : un changement de l'impédance mesurée et un changement de température.
  8. Appareil selon la revendication 7, comprenant un capteur de température (24) au niveau de l'extrémité distale de l'élément d'électrode (12).
  9. Appareil selon l'une quelconque des revendications précédentes, dans lequel l'élément d'électrode (12) comprend une borne d'anode, l'appareil comprenant un plot de cathode ; ou l'élément d'électrode (12) comprend des bornes d'anode et de cathode.
EP15275109.5A 2014-04-10 2015-04-02 Appareil d'occlusion d'un vaisseau par embolisation rf Not-in-force EP2939629B1 (fr)

Applications Claiming Priority (1)

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GB1406496.8A GB2525029B (en) 2014-04-10 2014-04-10 Apparatus and method for occluding a vessel by RF embolization

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EP2939629A2 EP2939629A2 (fr) 2015-11-04
EP2939629A3 EP2939629A3 (fr) 2016-02-24
EP2939629B1 true EP2939629B1 (fr) 2020-06-24

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Publication number Publication date
US20180325589A1 (en) 2018-11-15
GB2525113A (en) 2015-10-14
GB2525029A (en) 2015-10-14
GB2525029B (en) 2016-02-24
US20150289930A1 (en) 2015-10-15
EP2939629A3 (fr) 2016-02-24
GB201406496D0 (en) 2014-05-28
US10052151B2 (en) 2018-08-21
EP2939629A2 (fr) 2015-11-04
GB2525113B (en) 2016-02-24
GB201513105D0 (en) 2015-09-09

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